(367 days)
No
The device description details a standard immunochromatographic assay based on chemical reactions and visual interpretation of colored bands, with no mention of computational analysis, algorithms, or learning processes.
No
The device is an in-vitro diagnostic test designed to detect the presence of specific substances in urine, providing preliminary analytical results. It does not provide treatment or directly manage a patient's condition, which are characteristics of a therapeutic device.
Yes
The device is described as an "in-vitro test designed for qualitative determination of oxycodone in human urine specimens" and for "qualitative determination of the major metabolite of buprenorphine... in human urine specimens," used to provide "preliminary analytical test result." These functions align with the definition of a diagnostic device, which is used to detect or identify a disease or condition.
No
The device description clearly states it is a "Test Strip" and describes an immunochromatographic assay, which is a physical test strip that reacts with a urine sample. This is a hardware-based device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The description explicitly states that the test strips are "immunochromatographic one-step in-vitro test designed for qualitative determination of oxycodone in human urine specimens" and "immunochromatography based one step in vitro test. It is designed for qualitative determination of the major metabolite of buprenorphine... in human urine specimens". The term "in-vitro" is a direct indicator of an IVD.
- Device Description: The description details how the device works by analyzing "particular compounds in human urine specimens," which is a biological sample tested outside of the body.
- Intended User / Care Setting: While it mentions point-of-care use, the nature of testing human urine for the presence of substances falls under the definition of an IVD.
The core function of the device is to perform a diagnostic test on a biological sample (urine) outside of the body to detect the presence of specific substances (oxycodone and buprenorphine metabolite), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MP RapidOXY Test Strip is an immunochromatographic one-step in-vitro test designed for qualitative determination of oxycodone in human urine specimens above a cut-off level of 100 ng/ml.
The MP RapidOXY Test Strip may be used in a point-of-care (POC) setting and will provide preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
The MP RapidBUP Test Strip is an immunochromatography based one step in vitro test. It is designed for qualitative determination of the major metabolite of buprenorphine, buprenorphine-3-β-d-glucuronide, in human urine specimens at cut-off level of 10 ng/ml.
The MP RapidBUP Test Strip may be used in a point-of-care (POC) setting and will provide preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
Product codes
DJG
Device Description
Rapid Diagnostics, a division of MP Biomedicals, LLC, has developed two additional drug-of-abuse tests kits for the detection of oxycodone and buprenorphine in human urine samples. These two test strips complement the current panel for DOA analysis, the MICROMEDIC® Drugs of Abuse Panel Test (K033566). The MICROMEDIC® Drugs of Abuse Panel Test is an immunochromatographic one-step in vitro diagnostic test designed for the qualitative determination of up to nine (9) drug substances in human urine specimens to include amphetamines, barbiturates, benzodiazepine, cocaine, methadone, methamphetamine, opiates, phencyclidine (PCP) and cannabinoid (THC).
Both the MP RapidOXY Test Strip and the MP RapidBUP Test Strip are based on the principle of specific immunochemical reaction between antibodies and antigens to analyze particular compounds in human urine specimen. The tests rely on the competition for antibody binding between drug conjugate and free drug which may be present in the urine specimen being tested.
When the amount of drug is equal or more than the cut-off (i.e., 100 ng/ml oxycodone or 10 ng/ml buprenorphine-3-β-d-glucuronide, or B-3-β-d-G), it will prevent the binding of drug conjugate to the antibody. Therefore, a positive urine specimen will not show a colored band on the test line zone, indicating a positive result, while the presence of a colored band indicates a negative result.
A control line is present in the test window to work as procedural control in both assays. This colored band should always appear on the control line zone if the test device is stored in good condition and the test is performed appropriately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human urine specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
point-of-care (POC) setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
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PART 1 – Administrative Information
JUL 2 1 2006
510(k) SUMMARY II.
Product Information A.
Rapid Diagnostics, a division of MP Biomedicals, LLC, has developed two additional drug-of-abuse tests kits for the detection of oxycodone and buprenorphine in human urine samples. These two test strips complement the current panel for DOA analysis, the MICROMEDIC® Drugs of Abuse Panel Test (K033566). The MICROMEDIC® Drugs of Abuse Panel Test is an immunochromatographic one-step in vitro diagnostic test designed for the qualitative determination of up to nine (9) drug substances in human urine specimens to include amphetamines, barbiturates, benzodiazepine, cocaine, methadone, methamphetamine, opiates, phencyclidine (PCP) and cannabinoid (THC).
As will be demonstrated in the following three sections (Parts I, II, and III), both the MP RapidOXY Test Strip and the MP RapidBUP Test Strip are similar in format and intended use as the parent MICROMEDIC® DOA Panel Test. There are to be added to the existing test panel once cleared.
Both the MP RapidOXY Test Strip and the MP RapidBUP Test Strip are based on the principle of specific immunochemical reaction between antibodies and antigens to analyze particular compounds in human urine specimen. The tests rely on the competition for antibody binding between drug conjugate and free drug which may be present in the urine specimen being tested.
1
PART 1 - Administrative Information
II. 510(k) SUMMARY
B. Intended Use:
Oxycodone 1.
The MP RapidOXY Test Strip is an immunochromatography based one step in vitro test. It is designed for qualitative determination of oxycodone in human urine specimens above a cut-off level of 100 ng/ml. Each oxycodone test kit is used to obtain a visual, qualitative result and is submitted for point-of-care (POC) use. It is not intended for over the counter sale to lay persons.
The assay will provide a preliminary analytical test result, with recommended follow-up using gas chromatography/mass spectrometry (GC/MS) for a confirmatory result.
2. Buprenorphine
The MP RapidBUP Test Strip is also an immunochromatic, one-step in vitro test. It is designed for qualitative determination of buprenorphine's metabolite, buprenorphine-3-beta-d-qlucuronide, in human urine specimens above a cut-off level of 10 nq/ml.
As with the oxycodone test kit, the buprenorphine kit is used to obtain a visual, qualitative result and is submitted for point-of-care (POC) use. It is not intended for over the counter sale to lay persons. In addition, the assay will provide only a preliminary analytical test result, with recommended follow-up using GC/MS.
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PART 1 - Administrative Information
II. 510(k) SUMMARY
- Name of Manufacturer: Rapid Diagnostics, Inc. 1429 Rollins Road, C. Burlingame, California, USA, a division of MP Biomedicals, LLC, hereafter RAPID DIAGNOSTICS.
D. Principle
The MP RapidOXY Test Strip and the MP RapidBUP Test Strip are based on the principle of specific immunochemical reaction between antibody and antigen to analyze particular compounds in human urine specimens. The assays rely on the competition for binding antibody between drug conjugate and free drug which may be present in urine. When drug is present in the urine specimen, it competes with drug conjugate for the limited amount of antibodydve conjugate.
When the amount of drug is equal or more than the cut-off (i.e., 100 ng/ml oxycodone or 10 ng/ml buprenorphine-3-β-d-glucuronide, or B-3-β-d-G), it will prevent the binding of drug conjugate to the antibody. Therefore, a positive urine specimen will not show a colored band on the test line zone, indicating a positive result, while the presence of a colored band indicates a negative result.
A control line is present in the test window to work as procedural control in both assays. This colored band should always appear on the control line zone if the test device is stored in good condition and the test is performed appropriately.
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PART 1 -- Administrative Information
II. 510(k) SUMMARY
E. Submission Summary
In this Premarket Notification [510(k)], RAPID DIAGNOSTICS, Inc. will present information for clearance of the following two devices, the MICROMEDIC® MP RapidOXY Test Strip and the RapidBUP Test Strip, for use in a POC setting. The submission will consist of three parts, Part I, II and III, to include Administrative Information, the Performance Data and the Accuracy Data, respectively.
The submission consists of the required administrative and technical information, along with a detailed presentation of the clinical and laboratory data used to substantiate the POC claim.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized symbol in the center. The text around the perimeter is small and difficult to read, but it appears to be the name of an organization or agency. The symbol in the center consists of three curved lines that resemble a stylized human figure or a bird in flight. The logo is black and white and has a simple, clean design.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MP Biomedicals, LLC. c/o Ms. Robin J. Hellen Hellen Professional Services 9418 Lasaine Aveune Northridge, CA 91325
JUL 2 1 2006
Re: K051958 Trade/Device Name: RapidBUP Test Strip RapidOXY Test Strip Regulation Number: 21 CFR§ 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: June 15, 2006 Received: June 26, 2006
Dear Ms. Hellen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that I'DA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Garcia
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
and contract and consisted in the plant of the property that a first and the
STATEMENT FOR INDICATIONS FOR USE (BUPRENORPHINE)
510(k) Number (if known): | K051958 |
---|---|
Device Name: | RapidBUP Test Strip |
Indications for Use:
The MP RapidBUP Test Strip is an immunochromatography based one step in vitro test. It
is designed for qualitative determination of the major metabolite of buprenorphine,
buprenorphine-3-β-d-glucuronide, in human urine specimens at cut-off level of 10 ng/ml.
The MP RapidBUP Test Strip may be used in a point-of-care (POC) setting and will provide
preliminary analytical test result. A more specific alternative chemical method must be
used in order to obtain a confirmed analytical result. Gas chromatography/mass
spectrometry (GC/MS) has been established as the preferred confirmatory method by the
Substance Abuse Mental Health Services Administration (SAMHSA). Clinical onsideration
and professional judgment should be applied to any drug of abuse test result, particularly
when preliminary positive results are indicated.
Concurrence of the CDRH, Office of In-Vitro Diagnostic Device (OIVD)
Prescription Use: | X | OR | Over the Counter Use: |
---|---|---|---|
------------------- | --- | ---- | ----------------------- |
Division Sign-Off
Diagnostic Safety
7
STATEMENT FOR INDICATIONS FOR USE (OXYCODONE)
510(k) Number (if known): | K051958 |
---|---|
Device Name: | RapidOXY Test Strip |
Indications for Use:
The MP RapidOXY Test Strip is an immunochromatographic one-step in-vitro test designed for qualitative determination of oxycodone in human urine specimens above a cut-off level of 100 ng/ml.
The MP RapidOXY Test Strip may be used in a point-of-care (POC) setting and will provide preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
Concurrence of the CDRH, Office of In-Vitro Device (OIVD)
Prescription Use: X | OR | Over the Counter Use: ______ |
---|---|---|
--------------------- | ---- | ------------------------------ |
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety